Trial record 2 of 2 for:    Open Studies | "Pit and Fissure Sealants"

Effectiveness of Two Sealant Materials Over 5 Years

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Sahza Kofman, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01710865
First received: July 24, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to assess the effectiveness of a new hydrophilic sealant (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.


Condition Intervention
Caries
Other: Ultraseal Sealant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Changes in retention of sealants from baseline to five years [ Time Frame: Baseline and every year (baseline to five years) ] [ Designated as safety issue: No ]
    The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every year for 5 years.


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultraseal Sealant
Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.
Other: Ultraseal Sealant
This is a newly developed hydrophilic sealant material.
Other Name: Ultraseal XT Hydro
Other: Ultraseal Sealant
This is a previously existing hydrophobic sealant material.
Other Name: Ultraseal XT Plus

Detailed Description:

The new hydrophobic sealant material eliminates the step of prime and drying the tooth which prevents from over drying the tooth surface and decreases chair time, which is important when working with children. The null hypothesis is that there is no difference between the materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children that are at a high risk of developing caries.

Exclusion Criteria:

  • Children that already have sealants or do not need them.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710865

Contacts
Contact: Dr. Sahza Hatibov-Kofman, D.D.S.,FRCD 5196612111 ext 86131 sahza.kofman@schulich.uwo.ca

Locations
Canada, Ontario
Children's Clinic at Western University Not yet recruiting
London, Ontario, Canada, N6A2S9
Contact: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD    (519) 661-2111 ext 86131    sahza.kofman@schulich.uwo.ca   
Principal Investigator: Dr. Sahza Hatibov-Kofman Hatibov-Kofman, D.D.S.FRCD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD Division of Orthodontics and Paediatric Dentistry
  More Information

No publications provided

Responsible Party: Sahza Kofman, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01710865     History of Changes
Other Study ID Numbers: 041386
Study First Received: July 24, 2012
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lawson Health Research Institute:
Caries prevention
pit and fissure sealants

ClinicalTrials.gov processed this record on October 23, 2014